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Hydroxychloroquine in Giant Cell Arteritis

Primary Purpose

Giant Cell Arteritis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
hydroxychloroquine/placebo
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Arteritis focused on measuring giant cell arteritis,, hydroxychloroquine,, corticosteroid sparing,, corticodependence

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy
  • corticosteroid treatment since less than 1 month
  • age less than 85 years
  • signed informed consent

Exclusion Criteria:

  • amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA
  • low life expectancy (<2 years)
  • corticosteroid treatment since more than 30 days whatever the dosage
  • primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days
  • previous psychiatric troubles induced corticosteroids
  • hydroxychloroquine contra-indicated

Sites / Locations

  • Hospital
  • Hospital
  • Hospital Auch
  • Hospital Avignon
  • University Hospital Besançon
  • Hospital Béziers
  • University Hospital Côte de Nacre
  • University Hospital Dijon
  • Hospital
  • Hospital
  • University Hospital Dupuytren
  • Hospital
  • Hospital
  • Hospital
  • Hospital
  • University Hospital
  • Saint Louis Hospital
  • University Hospital Saint Antoine
  • University Hospital Bichat
  • Hospital Suresnes
  • University Hospital Toulouse
  • University Hospital
  • University Hospital Bretonneau

Outcomes

Primary Outcome Measures

prednisone dosage equal to or lower than 5 mg since more than 3 months without
having experienced relapse since the inclusion in the study

Secondary Outcome Measures

prednisone daily dosage
hydroxychloroquine blood levels

Full Information

First Posted
January 31, 2007
Last Updated
October 4, 2015
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00430807
Brief Title
Hydroxychloroquine in Giant Cell Arteritis
Official Title
Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
Keywords
giant cell arteritis,, hydroxychloroquine,, corticosteroid sparing,, corticodependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine/placebo
Primary Outcome Measure Information:
Title
prednisone dosage equal to or lower than 5 mg since more than 3 months without
Time Frame
3 months at least
Title
having experienced relapse since the inclusion in the study
Secondary Outcome Measure Information:
Title
prednisone daily dosage
Time Frame
6, 12, 18 and 24 months
Title
hydroxychloroquine blood levels

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy corticosteroid treatment since less than 1 month age less than 85 years signed informed consent Exclusion Criteria: amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA low life expectancy (<2 years) corticosteroid treatment since more than 30 days whatever the dosage primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days previous psychiatric troubles induced corticosteroids hydroxychloroquine contra-indicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ARLET Philippe, D
Organizational Affiliation
CHU Toulouse, Hôpital Purpan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SAILLER Laurent, MD
Organizational Affiliation
CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
Official's Role
Study Director
Facility Information:
Facility Name
Hospital
City
Agen
ZIP/Postal Code
47923
Country
France
Facility Name
Hospital
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Hospital Auch
City
Auch
ZIP/Postal Code
32008
Country
France
Facility Name
Hospital Avignon
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
University Hospital Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hospital Béziers
City
Beziers
ZIP/Postal Code
34525
Country
France
Facility Name
University Hospital Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
University Hospital Dijon
City
Dijon
ZIP/Postal Code
21035
Country
France
Facility Name
Hospital
City
Foix
ZIP/Postal Code
09017
Country
France
Facility Name
Hospital
City
Lavaur
ZIP/Postal Code
81500
Country
France
Facility Name
University Hospital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hospital
City
Lisieux
ZIP/Postal Code
14100
Country
France
Facility Name
Hospital
City
Lourdes
ZIP/Postal Code
65107
Country
France
Facility Name
Hospital
City
Mazamet
ZIP/Postal Code
81200
Country
France
Facility Name
Hospital
City
Montauban
ZIP/Postal Code
82013
Country
France
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Saint Louis Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
University Hospital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
University Hospital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hospital Suresnes
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11177313
Citation
Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, Fernandez-Gutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Jan 16;134(2):106-14. doi: 10.7326/0003-4819-134-2-200101160-00010.
Results Reference
background
PubMed Identifier
10852275
Citation
Chevalet P, Barrier JH, Pottier P, Magadur-Joly G, Pottier MA, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond JL, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L. A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients. J Rheumatol. 2000 Jun;27(6):1484-91.
Results Reference
background
PubMed Identifier
17009270
Citation
Mazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, Younge BR, Weyand CM, Goronzy JJ. Treatment of giant cell arteritis using induction therapy with high-dose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum. 2006 Oct;54(10):3310-8. doi: 10.1002/art.22163.
Results Reference
background
PubMed Identifier
7833883
Citation
Le Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournie B. [Treatment of Horton disease. Value of synthetic antimalarials. Apropos of a retrospective study of 36 patients]. Rev Rhum Ed Fr. 1994;61(7-8):485-90. French.
Results Reference
background
PubMed Identifier
6635510
Citation
David-Chausse J, Dehais J, Leman A. [Results of a regional survey on the treatment of rhizomelic pseudopolyarthritis and temporal arteritis. Apropos of 242 cases treated by various modalities with synthetic antimalarials, corticoids and non-steroidal anti-inflammatory agents]. Rev Rhum Mal Osteoartic. 1983 Jul-Sep;50(8-9):563-71. French.
Results Reference
background
PubMed Identifier
12115238
Citation
Hoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, Cohen P, Calabrese LH, Dickler H, Merkel PA, Fortin P, Flynn JA, Locker GA, Easley KA, Schned E, Hunder GG, Sneller MC, Tuggle C, Swanson H, Hernandez-Rodriguez J, Lopez-Soto A, Bork D, Hoffman DB, Kalunian K, Klashman D, Wilke WS, Scheetz RJ, Mandell BF, Fessler BJ, Kosmorsky G, Prayson R, Luqmani RA, Nuki G, McRorie E, Sherrer Y, Baca S, Walsh B, Ferland D, Soubrier M, Choi HK, Gross W, Segal AM, Ludivico C, Puechal X; International Network for the Study of Systemic Vasculitides. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002 May;46(5):1309-18. doi: 10.1002/art.10262.
Results Reference
background
Links:
URL
http://www.vascularites.org/
Description
Related Info
URL
http://www.snfmi.org/
Description
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Hydroxychloroquine in Giant Cell Arteritis

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